Dry Eye DiseaseNCT05168670
Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids
A study testing Protection of eyes with tinted soft scleral eye shields in people with Dry Eye Disease and Meibomian Gland Dysfunction, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids. Read more about this study
- Who is it for?
- Ages 22 to 120 years
- Conditions the study is for
- Dry Eye Disease, Meibomian Gland Dysfunction
- What is being tested?
- Protection of eyes with tinted soft scleral eye shields
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2021to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to read, understand and sign an IC form
- 22 or older
- Self-assessed symptoms are consistent with dry eye (SPEED score ≥ 10)
- Signs of MGD, as detected in biomicroscopy
- Fitzpatrick skin type I-V
- Subject is willing to comply with all study procedures, including return to the clinic 1 day and 1 week after the first and only treatment within the scope of the study
Who cannot join
- • Fitzpatrick skin type VI
- Ocular surgery or eyelid surgery, within 3 months prior to screening
- Recent ocular trauma, within 3 months prior to screening
- Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
- Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
- Uncontrolled infections or uncontrolled immunosuppressive diseases
Show all 19Show fewer
- Subjects with ocular infections requiring the use of antibiotic treatment, within 3 months prior to screening
- Legally blind in either eye
- Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., keratoconus, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, prior chemical burn)
- Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
- Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 \& 2, Systemic Lupus erythematosus, and porphyria
- Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
- Over exposure to sun, within 4 weeks prior to screening
- Moderate to severely compromised corneal health as assessed by corneal fluorescein staining
- Trans-illumination defects
- Anisocoria or pupil deformation
- Anterior chamber inflammation
- Media opacities (cataract, posterior capsule opacification, corneal edema, etc.) that preclude clear visualization of the anterior segment and retina
- Any condition revealed whereby the investigator deems the subject inappropriate for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Tinted Soft Scleral Eye Shields When IPL is Applied Directly on Eyelids of Subjects With Dry Eye Disease Due to Meibomian Gland Dysfunction
The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids.
Read the detailed description
Patients with dry eye disease due to meibomian gland dysfunction will be treated with one session of IPL applied directly on upper and lower eyelids, when eyes are protected with tinted soft scleral eye shields which prevent IPL from penetrating into ocular structures. Ocular structures will be examined with various tests (including: biomicroscopy, OCT and specular microscopy) at baseline and at 10 minutes after IPL, 24 hours after IPL, and 7 days after IPL. In addition, visual acuity will be measured at each of these times, and the patient will report of any visual symptoms at each of these times. The primary objective is to verify that no morphological or functional changes occur between the baseline and the 7 days follow-up visit.
- Conditions
- Dry Eye Disease, Meibomian Gland Dysfunction
- Being tested
- Protection of eyes with tinted soft scleral eye shields
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protection of eyes with tinted soft scleral eye shieldsCombination product
Also called IPL adminstration on eyelids
In subjects with dry eye disease due to meibomian gland dysfunction, protection of eyes with tinted soft scleral eye shields followed by IPL administration on eyelids
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Protection of eyes with tinted soft scleral eye shields followed by IPL administration directly on eyelids Receives: Combination Product: Protection of eyes with tinted soft scleral eye shields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ophthalmic morphological changes at 1 week after intervention
Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 1 week after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)
Measured: 1 week
Secondary outcomes (8)
Ophthalmic morphological changes at 10 minutes after intervention
Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 10 minutes after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)
Measured: 10 minutes
Ophthalmic morphological changes at 24 hours after intervention
Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 24 hours after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)
Measured: 24 hours
Objective functional change at 10 minutes after intervention
Change in best-corrected visual acuity (ETDRS chart) at 10 minutes after intervention
Measured: 10 minutes
Objective functional change at 24 hours after intervention
Change in best-corrected visual acuity (ETDRS chart) at 24 hours after intervention
Measured: 24 hours
Objective functional change at 1 week after intervention
Change in best-corrected visual acuity (ETDRS chart) at 1 week after intervention
Measured: 1 week
Subjective functional change at 10 minutes after intervention
Change in perception of visual symptoms (Visual analog scale) at 10 minutes after intervention
Measured: 10 minutes
Subjective functional change at 1 day after intervention
Change in perception of visual symptoms (Visual analog scale) at 1 day
after intervention
Measured: 1 day
Subjective functional change at 1 week after intervention
Change in perception of visual symptoms (Visual analog scale) at 1 week
after intervention
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start21 Dec 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolando Toyos, MD, Principal investigator, Toyos Clinic (Nashville, TN, USA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168670
- Sponsor's protocol ID
- LUM-VBU-OPT-21-02
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Tinted Soft Scleral Eye Shields When IPL is Applied Directly on Eyelids of Subjects With Dry Eye Disease Due to Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT05168670
- Acronym / sponsor ID
- LUM-VBU-OPT-21-02
- Conditions
- Dry Eye Disease, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids.
Detailed description
Patients with dry eye disease due to meibomian gland dysfunction will be treated with one session of IPL applied directly on upper and lower eyelids, when eyes are protected with tinted soft scleral eye shields which prevent IPL from penetrating into ocular structures. Ocular structures will be examined with various tests (including: biomicroscopy, OCT and specular microscopy) at baseline and at 10 minutes after IPL, 24 hours after IPL, and 7 days after IPL. In addition, visual acuity will be measured at each of these times, and the patient will report of any visual symptoms at each of these times. The primary objective is to verify that no morphological or functional changes occur between the baseline and the 7 days follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Combination Product: Protection of eyes with tinted soft scleral eye shieldsProtection of eyes with tinted soft scleral eye shields followed by IPL administration directly on eyelids |
Who may qualify
- Ages
- 22 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is able to read, understand and sign an IC form
- 22 or older
- Self-assessed symptoms are consistent with dry eye (SPEED score ≥ 10)
- Signs of MGD, as detected in biomicroscopy
- Fitzpatrick skin type I-V
Key exclusion criteria (19 listed)
- • Fitzpatrick skin type VI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protection of eyes with tinted soft scleral eye shieldsAlso: IPL adminstration on eyelidsIn subjects with dry eye disease due to meibomian gland dysfunction, protection of eyes with tinted soft scleral eye shields followed by IPL administration on eyelids | Combination product | Study arm |
Primary outcome
Ophthalmic morphological changes at 1 week after intervention
Time frame: 1 week
Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 1 week after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)
8 secondary outcomes
Ophthalmic morphological changes at 10 minutes after intervention
Time frame: 10 minutes
Ophthalmic morphological changes at 24 hours after intervention
Time frame: 24 hours
Objective functional change at 10 minutes after intervention
Time frame: 10 minutes
Objective functional change at 24 hours after intervention
Time frame: 24 hours
Objective functional change at 1 week after intervention
Time frame: 1 week
Subjective functional change at 10 minutes after intervention
Time frame: 10 minutes
Subjective functional change at 1 day after intervention
Time frame: 1 day
Subjective functional change at 1 week after intervention
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolando Toyos, MD principal investigator
Toyos Clinic (Nashville, TN, USA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protection of eyes with tinted soft scleral eye shields in people with Dry Eye Disease and Meibomian Gland Dysfunction, run by Lumenis Be Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ophthalmic morphological changes at 1 week after intervention (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.